Coordinator Regulatory Affairs II

HonorHealth
United States, Arizona, Phoenix
2500 West Utopia Road (Show on map)
Jan 24, 2025
Overview Looking to be part of something more meaningful? At HonorHealth, you'll be part of a team, creating a multi-dimensional care experience for our patients. You'll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit honorhealth.com/benefits to learn more. Join us. Let's go beyond expectations and transform healthcare together. HonorHealth is one of Arizona's largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses nine acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With nearly 16,000 team members, 3,700 affiliated providers and close to 1,100 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary This position coordinates, assesses, plans, and facilitates Regulatory Affairs at the Research Institute in the areas of training and compliance, system-wide use of Good Clinical Practice principals, and application of FDA and ICH guidelines. Responsible for the implementation and maintenance of study protocols from planning, through startup, lifecycle and closure. Studies range from industry-sponsored and investigator-initiated investigational agent, tissue acquisition, and chart/imaging review study protocols. Knowledge of clinical research trials regulations i.e., OHRP and the FDA, Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) is essential. Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports. This includes exempt, minimal risk and greater than minimal risk human research protocols. Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports. This includes exempt, minimal risk and greater than minimal risk human research protocols. Understand and coordinate with the Supervisor Regulatory Affairs, compliance with regulations as they apply to multi-center clinical research studies. Be knowledgeable of local, state and federal regulations that apply to human subject's research, including Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations, sponsor guidelines and all Standard Operating Procedures (SOP). Assist research staff and PIs in initiating, following-up, negotiating, and resolving issues regarding current and future submissions; participate in direct discussions with the appropriate regulatory agencies and other parties. Assist physicians and other staff in meeting human subject protection standards in research. As necessary, participate in creation of supporting documents for research involving human subjects. Interacts with the third party monitors for regulatory compliance and responds to regulatory queries. Execute and maintain a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents. Review sponsor guidelines for each study to ensure compliance with Standard Operating Procedures; suggest modifications as necessary for compatibility. Qualifications Education Bachelor's Degree or 4 years' work related experience Required Experience 2 years experience in clinical research, including data coordination, document and regulatory management, regulatory compliance, and quality assurance. Required